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NCT06389955Completed

Assessment of Relative Bioavailability and Effect of Food on Capsule and Tablet Formulations of TP-3654

A Phase 1, Randomized, Study in Healthy Volunteers to Assess Relative Bioavailability and Effect of Food on Capsule and Tablet Formulations of TP-3654
Sumitomo Pharma America, Inc.Phase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Healthy
Drug/Device/Intervention
TP 3654
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Sumitomo Pharma America, Inc.
Location
Secaucus, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
May 22, 2023
End date
Aug 24, 2023
Enrollment
12 participants
Primary outcome

Part A - The maximum concentration (Cmax) of TP-3654 in a capsule formulation,Part A - The area under the curve (AUC) of TP-3654 in a capsule formulation,Part A - Ratio of Peak Plasma Concentration (Cmax) of TP-3654 tablet versus TP-3654 capsule under fasted conditions,Part B - The maximum concentration (Cmax) of TP-3654 in a tablet formulation

Summary

This study comprised of 2 parts, Part A and Part B. Part B will only be conducted if the
 relative bioavailability of the tablet formulation was at least 70% of the capsule
 formulation.

ICD-10 classifications
ObesitySeeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmfulHealthy person accompanying sick personLifestyle-related conditionMalnutrition
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06389955
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06389955 through Pure Global AI's free database. This Phase 1 trial is sponsored by Sumitomo Pharma America, Inc. and is currently Completed. The study focuses on Healthy. Target enrollment is 12 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.